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Claim Substantiation for Cosmeceuticals
through Clinical Testing
AFFORDABLE, CREDIBLE, EFFICIENT RESEARCH
Vedic. Introduction
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A decade of experience as full and functional service CRO
Widest range of services for the Nutraceuticals, Dietary Supplements,
Botanical Drug Products, Medical Foods, Natural Health Products,
Cosmetics & Personal Care Products
Clinical trials for label claim substantiation
Compliant data to meet regulatory requirements
Efficient study design for testing cosmetic products
Cosmetic efficacy studies
Quality check of developed product
Delivery of safe and effective products to the customers.
ISO 9001:2008 certified
Headquarters in Mumbai, india with office in California, USA
Vedic. Services
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Services
Regulatory
Dossier
Preparation
& Consulting
Preclinical
Formulation
and
Standardization
Toxicology
Clinical
In vitro
&
In vivo
Animal
studies
Human
Bioavailability
Studies
Human
Clinical
Studies
Medical
Writing
Vedic. Benefits
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Experienced team of medical experts with experience in studies for Acne,
Melasma, Weight Loss, Hair removals, etc
Claim Substantiations possible - “Clinically Proven” tags at affordable
costs
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Protocols made in accordance with ICH-GCP
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Unmatched Quality, Effective Costs and Reduced Timelines
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End to end service provider for all your products
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Quality Research for better market acceptance
Vedic. Capabilities
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SKIN
HAIR
OTHERS
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Lightening/Fairness
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Cleaning /Conditioning
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Oral Hygiene
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Anti-ageing
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Growth stimulation
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Eye care
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Acne/oil control
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Growth retardation
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Weight Loss and
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Blemishes/Marks
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Dandruff Control
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Softness/Elasticity
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Styling / Colouring
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Body odour
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Repair
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Excessive sweating
Management
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Vedic. Site Capabilities
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Access to Right Set of Volunteers
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Comprehensive and Independent Facility
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Specialized in Cosmetics, Cosmeceutical and Dermatological Safety and
Efficacy studies
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Offer services to National and International sponsors for Safety as well as
Efficacy Testing
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Fulfill client’s expectations with Reliable, Consistent and Efficient
performance
Vedic. Invitro Tests
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Invitro screening of herbal extracts for cosmeceutical applications
Skin irritation
Phototoxicity
E.g: Invitro SPF testing: Estimation of protection from UVB (short wave
UV light) and UVA (long wavelength UV light)
Instrument Used: Optometrics LLC, SPF- 290S
Assist in product development stage
Vedic. Safety Studies – Standards & Methods
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Standards followed:
 ASTM
 BIS
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Primary Irritation Patch Test:
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To ascertain the safety in terms of irritation potential of the cosmetic
products against a positive control on the healthy human subjects
Repeat Insult Patch Test:
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The objective of this test is to determine the irritation and/or sensitization
potential of the test material(s) after repeated application under occlusive,
semi- occlusive or open patches to the skin of human subjects
The above are based on Client requests and preferences
Vedic. Clinical Studies Expertise
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Clinical studies compliant to ICH –GCP
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Experienced medical writing team
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Dedicated project management team
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ICH-GCP trained and qualified clinical research monitors
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Independent ethics committee approvals
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Evaluations for clinical studies based on:
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Expert dermatologist assessment
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Instrument assessment
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Self assessment carried out by the volunteers
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Comprehensive data management and statistical analysis
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Final report writing
Vedic. Investigators
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Rich experience in managing Dermatology and Venereology
patients
Dynamic, energetic and result oriented professionals
Ability to deliver quality data within specified timelines
Vedic. Instrumental Capabilities
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Instrument
Measures
Evaluates efficacy of
Visiometer®
Wrinkle Depth
Anti Ageing Products
Cutometer®
Skin Elasticity
Anti Ageing Products
Tewameter®
Skin Softness
Moisturizers
Chromameter®
Skin color according to pigmentation
Fairness creams, tanning products
Mexameter®
Skin melanin content / erythema
Fairness creams, tanning products,
anti-marks creams
Sebumeter®
Skin Oiliness
Anti-acne products
Corneometer®
Skin Moisture
Moisturizers
Visioscan®
Skin Surface Texture
Moisturizers
Skin Ph®
pH-level on the skin surface
Soaps, Face Wash
SKIN LIGHTENING
Visiometer®
Manufacturer: Courage + Khazaka electronic GmbH
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Studies the skin surface directly with Special UV-A light
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Shows the skin structure and level of dryness
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Evaluates desquamation and sebum production
Elasticity / Anti – ageing
Cutometer ®
Manufacturer: Courage + Khazaka electronic GmbH
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Measures precise skin elasticity
Cutometer Reading
Elasticity
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0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
0
10
20
30
40
50
60
70
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Age
The chart shows elasticity as a function of age
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Skin Softness
Tewameter ®
Manufacturer: Courage + Khazaka electronic GmbH
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Measures trans epidermal water loss
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Evaluates efficiency of the skin water barrier
Moisture-Locking Ability
6.0
TEWL (g/m2/h)
5.0
4.0
3.0
2.0
1.0
0.0
0
4
8
12
16
20
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No. of hrs
Lotion
Cream
Control
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Skin Fairness
Chromameter ®
Manufacturer: Konica Minolta
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Measures the skin color according to
L* Lightness
a* Redness
b* yellowness
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Skin Fairness
Mexameter ®
Manufacturer: Courage + Khazaka electronic GmbH
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Measure the two components, mainly responsible for the
colour of the skin:
Melanin and Hemoglobin (erythema)
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Skin oiliness
Sebumeter®
Manufacturer: Courage + Khazaka electronic GmbH
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Allows determination of even slightest changes in the skin
surface sebum content
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Measures oiliness in acne prone skin
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Skin softness
Corneometer ®
Manufacturer: Courage + Khazaka electronic GmbH
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Measures skin moisture levels
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Skin dryness
Visioscan®
Manufacturer: Courage + Khazaka electronic GmbH
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Measures the level of dryness of the skin
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Measures desquamation on skin and scalp
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Evaluates sebum production
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Skin pH
Skin-pH-Meter®
Manufacturer: Courage + Khazaka electronic GmbH
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Evaluates the quality of the Hydrolipidic film on the skin
especially in developing soaps, cleanser or detergents
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Vedic. Key people
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Jayesh Chaudhary is Founder & Managing Director of Vedic Lifesciences. He has been
involved in product development and international business since 1994. He is thorough with
regulatory affairs, research and marketing for nutraceutical and phyto-pharmaceutical actives
and formulations for the EU and US markets. Trained in Pharmacy and Microbial
Engineering from University of Minnesota, Jayesh was responsible for the Biocatalyst and
Natural Products technical support and national sales at Boehringer Mannheim India in the
early ‘90s.
• Dr. Navneet Sonawane is heading the Clinical Research Department. She has 12 years of
experience in the field of Medical Science & Clinical Research, which include areas such as
Medical Writing, Regulatory Affairs, Project Management & QA. She has successfully headed
Global Clinical Studies across various therapeutic segments. During her tenure at Vedic, she
has developed a strong network of GCP trained clinical investigators around India and has
been appreciated by Sponsors around globe. She places a high premium for meeting time line
while ensuring delivering of quality.
Vedic. Key people
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Kunal Bhatt has 8 years of experience within the pharmaceutical industry, having led
several Global Phase I - IV drug studies in various capacities and diverse therapeutic areas
like Neurology, Psychiatry (Adult and Pediatric), Oncology, Diabetes, Urology and Cardiology.
Masters in Pharmacology and Biotech from Sheffield Hallem University, UK, Kunal has worked
in areas of Global Project Management, Clinical Operations and Regulatory. As a Global
Business Development Manager his good business planning acumen and interpersonal relations
help in crafting Business & Marketing Plans.
ANIL YADAV leads VL’s QA department. After completing his graduation in
Microbiology he obtained a Master degree in Biochemistry from the Mumbai University.
He brings in over 7 years of experience in the field of Quality Assurance with actual
hands on experience in Product development, Documentation and Training.. His focus at
VL on System development and Training activities has helped in constant up-gradation of
our expertise and abilities.
Vedic. Key people
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Sakshi Pawar is involved in handling Feasibility and Project Management of trials at
Vedic and has over 11 years of professional experience in Clinical Research. During
this period she has actively participated in sponsor/regulatory audits, including those
conducted by USFDA, MHRA, EMEA and DCGI. . Sakshi has completed her
Diploma in Clinical Research and General Nursing and Midwifery. She has worked
for BA-BE studies.
Seema Damakale has got a total work experience of 7 years in Pharma and
Research industry. She has played various roles during her tenure, right from Sales
and Marketing to Quality Assurance and now, Project Management. With her
exuberance and dedication towards project work and her quest for meeting
timelines, she has been an excellent role model. Seema is a Science Graduate and
has completed her Post Graduate Diploma in Clinical Research and Diploma in
Business Management.
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India
203, Morya Landmark 1, Off new Link Road, Andheri West,
Mumbai 400053
Tel.: +91 22 42172300 / +91 22 42025719
USA
552, Shorebird Circle, Unit #1101, Redwood Shores, CA. 94065
Tel.: (650) 855-4832
[email protected], www.vediclifesciences.com